Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
2009 2015 2016 Images courtesy of Boston Scientific Patient Name Patient Name 2 INSIGHT™ Algorithm: Architecture PHA SE I: Detection Subcutaneous signal detection S-ECG signal similar to a surface ECG Risk Profile INSIGHT™ PHA SE II: Certification Heart rate determined PHA SE III: Therapy Decision 4 double-detection algorithms designed to reduce oversensing SMART Pass © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-384027-AA MAR2016 Slide courtesy of Boston Scientific HR assessed, therapy confirmed 3 rhythm discriminators to confirm therapy Priori et al. 2015 ESC VA and SCD guidelines Elliot et al. 2014 ESC HCM guidelines S-ICD is excellent at appropriately identifying (and not shocking) Afib/SVT in the conditional Reported shock rates Reportedinappropriate inappropriate shock rates zone and technology impact andprojected projected technology impact Inappropriate Therapy Rate 1-year incidence (% pts) of IAS 1-year incidence (% pts) of IAS (% of Patients, 360 days) Programming optimisation Programming optimisation Technology TechnologyImprovement Improvement EFFORTLESS Projection EFFORTLESSdata data Projection(bench (benchtesting) testing) 7.0% 4.0% 4.0% 12.0% 12.0% 9.0% 9.0% 6.0% 6.0% 4.8 Cardiac Over-sensing 0.2 7.0% 7.0% 0.8 Discrimination Error 5.1 -Noncardiac Over-sensing 5.1 3.9 -3.9 5.6% 5.6% 4.2% SVT above shock zone 4.2% MADIT-RIT: <65 MADIT-RIT: ≥65 MADIT-RIT: <65 MADIT-RIT: ≥65 years 8 8 years 8 8 years years 12.0% 12.0% 6.4% 6.4% 3.0% 3.0% 1.2 0.0% 0.0% » In the START3 study, the authors noted: “specificity of supraventric arrhythmia detection varied considerably among devices 2.5% 2.5% was best for the S-ICD sys 4 4 Single zone zone SMR8 SMR8 && Single zone 4 Dual Dual zone 4 EFFORTLESS EFFORTLESS SMR8 SMR8 44 EFFORTLESS 4 (blended total) Pass (blended total) Projection* Projection* SMART SMART Pass Projection** Projection** Priori et al. 2015 ESC VA and SCD guidelines There was only 1 discrimination error (in the conditional zone) in 456 patients 2.8% 2.8% 3.1% 3.1% MADIT RIT MADIT RIT MADIT RIT MADIT RIT 6 6 6 6 (high rate) (delayed) (high rate) (delayed) 3.6% 3.6% 7 PREPARE PREPARE 7 Slide courtesy of Boston Scientific * Estimated number based on on bench testing showing 30-3040% reduction ofINSIGHT™ Toversensing with thethe addition of the Alternating Morphology Algorithm in the heart rate certification Risk Profile SMART Pass * Estimated number based bench testing showing 40% reduction of wave T-wave oversensing with addition of the Alternating Morphology Algorithm in the heart rate certification # phase of the EMBLEM S-ICD INSIGHT™ Technology on on filefile at Boston Scientific, validation report DN23333) # (Data phase of the EMBLEM S-ICD INSIGHT™ Technology(Data at Boston Scientific, validation report DN23333) 38 ** Estimated number on on bench testing showing > 40% reduction of inappropriate therapy with thethe addition of SMART Pass filter ** Estimated number bench testing showing > 40% reduction of inappropriate therapy with addition of SMART Pass filter 38 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-384027-AA MAR2016 Reported inappropriate shock rates and projected technology impact nce (% pts) of IAS Programming optimisation EFFORTLESS data 4.0% 12.0% 2.5 9.0% Gen 1: SQ-RX ⎮ Gen 2: EMBLEM™ S-ICD ⎮ Gen 2.5: EMBLEM™ MRI 6.0% Technology Improvement Projection (bench testing) 12.0% MADIT-RIT: <65 MADITyears 8 ye Acute major implant-related: 2% (TV-ICD: VR 1.9%, DR 2.9%)2 No systemic infection No electrode failures IDE + EFFORTLESS N = 8821 Patient Name AF Monitor ™ Algorithm AF Monitor ™ Algorithm 1. Ventricular Scatter Algorithm AF Monitor™ uses Ventricular scatter and HRDI algorithms™ AF Monitor to identify and classify rhythm1 (based on internal bench testing) 1. Ventricular Scatter Algorithm 2. Heart Rate Distribution Algorithm 2. Heart Rate Distribution Algorithm RR1 RR2 RR3 RR4 RR5 non-AF episode Heart Rate Density Index = 81% Heart Rate Mode = 60bpm AF episode Input Heart Rate Density Index = 81%Beat by Beat Heart Rate Mode = 60bpmHeart250 Rate AF episode Ventricular Scatter Algorithm: AF/non-AF Rate 250 Rate non-AF episode Algorithm 40 (Based on RR interval) Classify: AF/non-AF 40 time Heart Rate Density Index Algorithm: AF/non-AF (Based on heart rate distribution) time Heart Rate Density Index = 23% Heart Rate Mode = 90bpm Heart Rate Density Index = 23% Heart Rate Mode = 90bpm Both Ventricular Scatter and HRDI algorithms need to be met in a 192 beat window for the rhythm to be classified as AF1. AF Prevalence AF Prevalence AF Monitor™ Benefit AF Monitor™ Algorithm AF Monitor™ Benefit AF Monitor™ Algorithm AF Monitor™ AF Prevalence Programming © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016 AF Monitor™ Algorithm AF Monitor™ Programming © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016 AF Monitor™ Programming AF Monitor™ Benefit Slide courtesy of Boston Scientific Patient Name Tachy Therapies -Future Product Pipeline EMBLEM™ S-ICD + Leadless Cardiac Pacemaker Design Parameters Patient Experience Quality Outcomes Operational Efficiency Financial Health Design Goals Coordinate S-ICD with leadless pacemaker. Convert arrhythmias with ATP instead of a shock. Allow leadless pacemaker to be added any time after initial S-ICD implant with femoral access, instead of adding a transvenous system. Give even more people access to the S-ICD by offering a combined S-ICD plus Leadless pacemaker system. Caution: Investigational devices. Limited by Federal law to investigational use only. Not available for sale. ©Boston Scientific 2015 Slide courtesy of Boston Scientific Advantages Disadvantages Less lead failure No anti-bradycardia pacing or CRT No systemic infection No ATP Preserved vascular access Lack of long term follow-up No/less fluoroscopy Shorter battery life No risk of transvenous lead extraction Higher risk of IAS Predictability of implantation Limited programming options Less procedural risk Higher cost 2 • • • • • “Sicker” patients : - renal failure, - coagulopathy, - weight loss.